NIGHT NURSE HOT LEMON MENTHOL

Route of Administration Oral Adults and children 16 years and over:

Empty contents of one sachet into a mug. Half fill with very hot water. Stir well. Add cold water as necessary. One sachet to be taken just before going to bed. Not to be given to children under 16 years except on medical advice.

Maximum daily dose:

Only one sachet should be taken per night. Do not exceed the stated dose Maximum duration of continued use without medical advice: 3 days. Other products containing paracetamol may be taken during the day but the total daily dose of paracetamol must not exceed 4000mg (including this product) in any 24 hour period.

Allow at least four hours between taking any paracetamol-containing product and this product. Should not be used with other cough or cold medicines, or any other antihistamine-containing products, including those used on the skin.

The following convention has been utilized for the classification of undesirable effects: very common (≤ 1/10), common (≤ 1/100, <1/10), uncommon (≤ 1/1000, < 1/100), rare (≤ 1/10,000, < 1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

Paracetamol Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post- marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. **There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Dextromethorphan The following adverse events have been observed in published clinical studies and are likely to represent uncommon adverse reactions to dextromethorphan. Body system Undesirable effect Nervous system disorders Drowsiness, dizziness Gastrointestinal disorders Gastrointestinal disturbance, nausea, vomiting, abdominal discomfort Adverse reaction identified during post-marketing use with dextromethorphan are listed below.

The frequency of these reactions is unknown but likely to be very rare. g. 4) General disorders and administration site conditions Drug withdrawal syndrome Promethazine Adverse reactions which been observed in published clinical studies with promethazine and which are considered to be common or very common are listed below by MedDRA system Organ Class.

The frequency of other reactions identified during post-marketing use is not known, but these reactions are likely to be uncommon or rare. g. increased energy, irritability, restlessness, nervousness, sleep disturbance), hallucinations, aggression *The elderly are more susceptible to confusion, disorientation and paradoxical excitation **Children are more susceptible to paradoxical excitation Nervous system disorders Very common: Drowsiness Common: Psychomotor impairment, disturbance in attention, dizziness, headache.

Not known: neuroleptic malignant syndrome, psychomotor hyperactivity Eye disorders Common: Blurred vision Cardiac disorders Not known : QT prolongation, Torsade de pointes Gastrointestinal disorders Common: Dry mouth Not Known: Gastrointestinal disturbance Renal and urinary disorders Not known: Urinary retention The elderly are more susceptible to anticholinergic effects of promethazine.

Contains paracetamol. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines.

Medical advice must be sought before taking this product in people with: • Severe renal or hepatic impairment. Underlying liver disease increases the risk of paracetamol-related liver damage. The hazards of overdose are greater in those with non-cirrhotic liver disease.

• Chronic or persistant cough, such as occurs with asthma and emphysema, chronic bronchitis or where cough is accompanied by excessive secretions. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.

If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

g. atropine) Use with caution in the elderly, who are more likely to experience anticholinergic adverse effects including confusion and paradoxical excitation. Avoid use in elderly patients with confusion. Children are more likely to experience paradoxical excitation with sedating antihistamine.

Medical advice should be sought if symptoms persist, or are accompanied by high fever, skin rash or persistent headache. Patients with rare glucose-galactose malabsorption should not take this medicine. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose. Patients should be advised not to take other paracetamol-containing products or decongestant-containing medicines concurrently. If symptoms persist consult your doctor. Keep out of the sight and reach of children.

Avoid alcoholic drink. Cases of dextromethorphan abuse and dependence have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.

Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.

Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Night Nurse should be discontinued. Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.

, major depression). Drug withdrawal syndrome The drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.

Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan.

5). Promethazine may interfere with immunologic urine pregnancy tests to produce false positive or negative results. Special label warnings Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Special leaflet warnings Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. e. 9g) per dose, equivalent to 72 ml beer, 30 ml wine per dose.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high- risk groups such as patients with liver disease, or epilepsy. 8 g glucose. This should be taken into account by patients with diabetes mellitus.

Each 20 ml dose contains 37 mg sodium. This should be taken into account by patients on a controlled sodium diet. QT interval As phenothiazines can prolong the QT interval, caution is advised in treated patients with pronounced bradycardia, cardiovascular disease, with a hereditary form of prolongation of the QT […]

Hypersensitivity to paracetamol, dextromethorphan, promethazine or any of the other constituents. g. those with chronic obstructive airways disease or pneumonia, or during an asthma attack or an exacerbation of asthma). Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in the last two weeks.